Educational Offerings
| September 23, 2020 |
Human Subjects Research 101: From Inspiration to Approval! |
video/slide deck |
| This session explains why we have an IRB process, lists types of human subjects research and levels of review, outlines Ohio State’s IRB review process, and generates an action plan for completing a successful social and behavioral sciences Buck-IRB application. Note: A medically focused session was presented on May 20, 2020, and is available below.
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| September 10, 2020 |
FDA-regulated Research: Myth vs. Reality – Part 1: Drugs |
video/slide deck |
| This session explains common regulatory terms in the context of FDA-regulated drug studies, assesses which regulations apply to clinical investigations involving drugs or biologics, including when an Investigational New Drug Application (IND) is required, navigates the Buck-IRB application sections and documents required for FDA-regulated drug research, and discusses how and when to consult the FDA.
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| February 2, 2021 |
FDA-regulated Research: Myth vs. Reality – Part 2: Medical Devices |
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| Although OHRP and FDA regulations are similar, differences exist based on FDA’s unique scope and requirements. These sessions focus on research involving medical devices and the special considerations associated with obtaining IRB approval.
The first recording explains common regulatory terms in the context of FDA-regulated medical device studies, differentiates between clinical investigations requiring Investigational Device Exemptions (IDEs), Nonsignificant Risk device investigations, and IDE-exempt investigations, and how and when to consult the FDA.
The second session covered applying regulatory information from the pre-recorded session to real-life examples of medical device research, using tools to determine which of the five most common device research scenarios applies to your research, identifying supporting documents required for medical device research and completing Buck-IRB application sections required for FDA-regulated medical device research.
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| June 17, 2021 |
University HIPAA Policy: What It Means for Your Research |
video/slide deck |
| This session describes how the new university policy “HIPAA and Protected Health Information” applies to research, defines “Research Health Information (RHI)” and identifies appropriate security protections, lists the mechanisms by which HIPAA-protected data (PHI) may be disclosed as RHI for research purposes, and applies these concepts to real-world examples of research. |
